Recruiting

Low-Load ResistanceUnderstanding the Effects of Pulmonary Arterial Hypertension on Lean Muscle Mass-Substudy

Sponsor:

University of Pennsylvania

Code:

NCT07781709

Conditions

Pulmonary Arterial Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Measurement of oxyhemoglobin and deoxyhemoglobin concentration pre and post- exercise at baseline and Week 12. Measurement of time to recovery of oxyhemglobin post-exercise at baseline and at Week 12.

Blood draw

Study Details

Brief summary:

After completion of the Baseline study visit for the main study (MUSCLE UP-PH), participants at the University of Pennsylvania location will be invited to participate in an optional substudy. The substudy will implement a low-load resistance exercise training for the lower extremities, focusing primarily on the gastrocnemius muscles. The goal of this intervention is to understand how low-load resistance training will impact blood flow and oxygen tissue extraction on the lower legs.

Conditions

Pulmonary Arterial Hypertension

Study ID

NCT07781709

Start date

Nov 2, 2026

Status verified date

Nov, 2026

Completion date

Jul 1, 2029

Anticipated

Primary completion date

Jul 1, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria: Participating the main MUSCLE UP Study:

Signed informed consent prior to initiation of any study mandated procedure.
Male and female patient's ≥ 18 years of age.
Diagnosis of PAH belonging to one of the following subgroups of Group 1 PH according to the updated clinical classification \[Humbert 2022\]
Idiopathic (IPAH)
Heritable (HPAH)
Drugs or toxins induced
Associated (APAH) with one of the following:
Connective tissue disease;
Human immunodeficiency virus (HIV) infection;
Congenital heart disease; or
Portopulmonary hypertension
Diagnosis of PAH within 6 months of enrollment or diagnosis of PAH and on stable therapy for 3 months prior to enrollment
Documented hemodynamic diagnosis of PAH by right heart catheterization (RHC), prior to enrollment showing:
mPAP > 20 mmHg; and
PAWP or LVEDP ≤ 15 mmHg
PVR > 2 Wood units

Exclusion Criteria:

Prior to enrollment, evidence of moderately severe obstructive ventilator defect with:
FEV1/FVC ≤ 5th percentile; and
FEV1 z-score < -2.5
Prior to enrollment, evidence of severe restrictive defect with
TLC < 5th percentile
FEV1 z-score < -4
More than moderate aortic or mitral valve disease
LVEF < 40% within 1 year of screening
Pregnancy

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Low resistance exercise intervention

Participants will be asked to perform a series of exercises recommend by the National Institute on Aging Go4Life campaign, namely seated heel raise, plantar flexion, sit to stand, and box squats. They will wear the portamon device to measure muscle oxygenation and have blood drawn to measure adiponectin before performing the above exercises at home for 12 weeks, and then be measured with the portamon device and undergo another flood draw again after 12 weeks.

Interventions

: The investigators will measure oxy-hemoglobin and deoxyhemoglobin concentration using NIRS applied to the biceps and calf pre- and post- exercise at baseline and Week 12. Moreover, the investigators will measure time to recovery of oxy-hemglobin post-exercise at baseline and at Week 12. Time Frame: 12 weeks

Blood draw

: The investigators will measure adiponectin levels using a solid phase sandwich ELISA (R\&D Systems, Inc., Minneapolis, MN) with a minimum detectable dose of 0.246 ng/mL and intra-assay variations (CV) 2.5%-4.7%.Time Frame: 12 Weeks

Primary outcome measure

Difference in circulating level of adiponectin (ng/mL) pre- and post-exercise at baseline and at Week 12 [ Time Frame: 12 Weeks ]

Central Contacts and Locations

Central contacts

Rebecca Gallagher Research Project Manager, MSEd

215-662-4088 rebecca.lang@pennmedicine.upenn.edu

Nicole Denney, MS

215-615-4156 nicole.denney@pennmedicine.upenn.edu

Locations

University of Pennsylvania Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Nicole Denney, MS

215-294-9755 Nicole.denney@Pennmedicine.upenn.edu

Principal Investigator:

Nadine Al-Namaani, MD

More Information

Sponsor

University of Pennsylvania

Last update posted

Nov 10, 2026

Last verified

Nov, 2026

Keywords

PAH
Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-11. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.